BioSpace News Archive

In a change of position as congressional scrutiny of WuXi AppTec grows, the Biotechnology Innovation Organization announced it is taking steps to separate from the China-based biotech.

At the center of the deal is Amolyt Pharma’s late-stage candidate eneboparatide for the rare disease hypoparathyroidism. AstraZeneca also gains ownership of AZP-3813, which is being assessed for acromegaly in a Phase I trial.

The German biotech Thursday said the proceeds from the Series B2 round will support clinical evaluation of its lead solid tumor antibody-drug conjugate candidates and expansion into the U.S.

A lawsuit filed by the Pharmaceutical Research and Manufacturers of America failed to block an Arkansas law that empowers hospitals to use outside pharmacies to dispense discounted drugs.

This episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.

The U.K. National Institute for Health and Care Excellence on Thursday recommended against funding Vertex Pharmaceuticals’ CRISPR-based sickle cell disease therapy Casgevy unless uncertainties can be cleared up.

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.

Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.

Merck is looking to expand its offerings in the human papillomavirus space with a new vaccine and to study a single-shot variant of Gardasil 9, both of which will start trials toward the end of 2024.

List Biotherapeutics, Inc. and Sacco System Australia Pty Ltd announced a lead share agreement to introduce and mutually recommend each other’s microbial development and manufacturing services to prospective customers if one party discovers a project that is better suited to the other party’s capability or capacity.